The Tyrolean early vascular ageing-study (EVA-Tyrol): study protocol for a non-randomized controlled trial : Effect of a cardiovascular health promotion program in youth, a prospective cohort study.
Adolescent
Adolescent Behavior
Age Factors
Austria
/ epidemiology
Cardiovascular Diseases
/ diagnosis
Counseling
Female
Health Behavior
Health Knowledge, Attitudes, Practice
Health Promotion
Healthy Lifestyle
Humans
Male
Multicenter Studies as Topic
Non-Randomized Controlled Trials as Topic
Prospective Studies
Protective Factors
Risk Factors
Risk Reduction Behavior
School Health Services
Journal
BMC cardiovascular disorders
ISSN: 1471-2261
Titre abrégé: BMC Cardiovasc Disord
Pays: England
ID NLM: 100968539
Informations de publication
Date de publication:
05 02 2020
05 02 2020
Historique:
received:
26
07
2019
accepted:
22
01
2020
entrez:
7
2
2020
pubmed:
7
2
2020
medline:
30
9
2020
Statut:
epublish
Résumé
According to the World Health Organization, cardiovascular diseases (CVDs) are the leading non-communicable cause of death. Awareness of the individual risk profile is crucial to implement a healthy lifestyle and prevent CVDs. Multiple studies demonstrated that atherosclerosis, the main cause of CVDs, begins early in life. Therefore, it may be necessary to start prevention programs already in childhood. The EVA-Tyrol study is a population-based non-randomized controlled trial that will prospectively enroll 2000 participants from high schools and training companies in North- and East-Tyrol (Austria) and South-Tyrol (Italy). Participants will be assigned to either an intervention (n = 1500) or a control (n = 500) group. Intervention group participants will be enrolled at the 10th school grade (mean age 15-16 years), undergo two examinations within a two-year interval, with follow-up at the 12th grade (mean ages 17-18 years). Control group participants will be enrolled at the 12th grade (mean age 17-18 years). Medical examination will include anthropometric measurements, comprehensive lifestyle and dietary questionnaires, a fasting blood sample, high-resolution ultrasound of the carotid arteries, and measurement of carotid-femoral pulse wave velocity. Active intervention will consist of (1) enhancing knowledge about CVDs, (2) individual medical counseling based on the results of the baseline examination, (3) an online health promotion tool and (4) involvement of participants in planning and implementation of health promotion projects. Effectiveness of the intervention will be assessed by comparing the proportion subjects with ideal health metrics as defined by the American Heart Association between study groups. This study aims to improve cardiovascular health in Tyrolean adolescents by demonstrating the efficacy of a multi-layer health promotion program and may yield novel insights into the prevalence of vascular risk conditions and mechanisms of early vascular pathologies in adolescents. EVA-Tyrol has been retrospectively registered at clinicaltrials.gov under NCT03929692 since April 29, 2019.
Sections du résumé
BACKGROUND
According to the World Health Organization, cardiovascular diseases (CVDs) are the leading non-communicable cause of death. Awareness of the individual risk profile is crucial to implement a healthy lifestyle and prevent CVDs. Multiple studies demonstrated that atherosclerosis, the main cause of CVDs, begins early in life. Therefore, it may be necessary to start prevention programs already in childhood.
METHODS
The EVA-Tyrol study is a population-based non-randomized controlled trial that will prospectively enroll 2000 participants from high schools and training companies in North- and East-Tyrol (Austria) and South-Tyrol (Italy). Participants will be assigned to either an intervention (n = 1500) or a control (n = 500) group. Intervention group participants will be enrolled at the 10th school grade (mean age 15-16 years), undergo two examinations within a two-year interval, with follow-up at the 12th grade (mean ages 17-18 years). Control group participants will be enrolled at the 12th grade (mean age 17-18 years). Medical examination will include anthropometric measurements, comprehensive lifestyle and dietary questionnaires, a fasting blood sample, high-resolution ultrasound of the carotid arteries, and measurement of carotid-femoral pulse wave velocity. Active intervention will consist of (1) enhancing knowledge about CVDs, (2) individual medical counseling based on the results of the baseline examination, (3) an online health promotion tool and (4) involvement of participants in planning and implementation of health promotion projects. Effectiveness of the intervention will be assessed by comparing the proportion subjects with ideal health metrics as defined by the American Heart Association between study groups.
DISCUSSION
This study aims to improve cardiovascular health in Tyrolean adolescents by demonstrating the efficacy of a multi-layer health promotion program and may yield novel insights into the prevalence of vascular risk conditions and mechanisms of early vascular pathologies in adolescents.
TRIAL REGISTRATION
EVA-Tyrol has been retrospectively registered at clinicaltrials.gov under NCT03929692 since April 29, 2019.
Identifiants
pubmed: 32024473
doi: 10.1186/s12872-020-01357-9
pii: 10.1186/s12872-020-01357-9
pmc: PMC7001281
doi:
Banques de données
ClinicalTrials.gov
['NCT03929692']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
59Subventions
Organisme : Competence centers for excellent techologies - Comet (AT)
ID : K-Project No. 843536
Pays : International
Investigateurs
Mandy Asare
(M)
Manuela Bock-Bartl
(M)
Maximilian Bohl
(M)
Christina Burger
(C)
Gregor Brössner
(G)
Tatjana Heisinger
(T)
Christoph Hochmayr
(C)
Julia Klingenschmid
(J)
Martina Kothmayer
(M)
Julia Marxer
(J)
Raimund Pechlaner
(R)
Maximilian Pircher
(M)
Carmen Reiter
(C)
Sophia J Kiechl
(SJ)
Bernhard Winder
(B)
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